Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Lepto… (NCT06537297) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Leptomeningeal Metastases
China30 participantsStarted 2024-09-30
Plain-language summary
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 1\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
* 2\. Age ≥ 18 years.
* 3\. Histopathology confirmed Non-small cell lung cancer.
* 4\. confirmed or probable leptomeningeal metastases according to EANO-ESMO guidelines or known leptomeningeal metastases progression after third generation of EGFR-TKIs failure.
* 5.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA (cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent with typical meningeal metastases.
* 6.ECOG 0 - 2.
* 7\. Predicted survival ≥ 12 weeks.
* 8\. Adequate bone marrow hematopoiesis and organ function.
Exclusion Criteria:
* 1\. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.
* 2\. Subjects who have received any of the following treatments must be excluded: Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
* 3\. Presence of spinal cord compression.
* 4\. History of other malignant tumors within 2 years.
* 5\. Adverse events (except alopecia of any degree) of CTCAE \> grade 4 due to prior treatment (e.g., adjuvant chemo…
What they're measuring
1
LM-overall survival
Timeframe: Time from first subject dose to study completion, or up to last follow up